CONSHOHOCKEN, PA — Madrigal Pharmaceuticals Inc. (Nasdaq: MDGL) will present new clinical and real-world research on its liver disease treatment Rezdiffra at a medical conference in Denver beginning November 5, expanding the evidence supporting the drug’s use in routine care as the company works to establish its position in the market for metabolic dysfunction-associated steatohepatitis.
The research includes data from more than 12,000 patients in the largest dataset and examines treatment effectiveness, tolerability, adherence and persistence outside controlled clinical trials.
Madrigal plans to present 13 abstracts from its RESONANCE real-world evidence program during the American Association for the Study of Liver Diseases’ annual Liver Meeting, scheduled for November 5-9.
The studies draw on multiple sources, including electronic health records, insurance claims, pharmacy records and health system data, to evaluate how patients receiving Rezdiffra respond to treatment and remain on therapy.
The research is particularly relevant to Madrigal’s commercialization strategy because Rezdiffra was the first medication approved for metabolic dysfunction-associated steatohepatitis, or MASH, in the United States and Europe.
The once-daily oral medication, also known as resmetirom, targets thyroid hormone receptor beta in the liver. It is approved for adults with noncirrhotic MASH and moderate to advanced liver fibrosis, consistent with stages F2 to F3, when used alongside diet and exercise.
The indication remains subject to confirmatory clinical research, with continued approval potentially dependent on verification of clinical benefit.
Madrigal’s latest analyses will examine changes in noninvasive measures of liver health over as long as 12 months, along with treatment patterns and patient persistence in everyday clinical settings.
“Real-world evidence is essential to understanding how treatment is working outside the clinical trial setting,” David Soergel, Madrigal’s chief medical officer, stated.
Soergel indicated that findings across multiple datasets show improvements in measures of liver health through 12 months, providing additional information about treatment response beyond the original clinical trials.
Other clinical abstracts will examine the drug’s effects on cardiovascular risk markers, noninvasive indicators of treatment response and patient-reported outcomes.
The research builds on the Phase 3 MAESTRO-NASH trial, in which Rezdiffra met its primary endpoints for improvement in liver fibrosis and resolution of MASH.
That study also demonstrated reductions in liver stiffness, liver fat, liver enzymes and atherogenic lipids, along with improvements in health-related quality of life.
At one year, 91% of patients receiving the 100-milligram dose experienced improvement or stabilization of liver stiffness as measured by vibration-controlled transient elastography, a noninvasive test used to assess liver health.
The distinction between clinical trial results and real-world evidence is important as physicians evaluate treatment effectiveness across broader patient populations, including individuals whose characteristics and treatment patterns may differ from those enrolled in controlled studies.
MASH is a progressive liver disease associated with inflammation, scarring and potentially severe complications, including cirrhosis, liver failure and liver cancer.
Patients with moderate to advanced fibrosis face a substantially elevated risk of liver-related mortality compared with those without fibrosis. The disease is also associated with cardiovascular complications, a major cause of death among affected patients.
Rezdiffra is intended for treatment before cirrhosis develops and is not approved for patients with cirrhosis.
The upcoming presentations will add to Madrigal’s post-approval research program as the company collects evidence on how Rezdiffra performs across healthcare settings and patient populations.
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